Another Pfizer pain drug candidate flops, as firm suspends tanezumab clinical trial program

Pfizer, the world's largest drugmaker by sales, had another disappointment for its R&D efforts, announcing yesterday that, at the request of the US Food and Drug Administration, it has suspended the chronic low back pain and painful diabetic peripheral neuropathy studies in the clinical program for the investigational compound tanezumab. Investigation of the compound continues in some areas of high unmet medical need, including cancer pain.

The FDA's request follows further consideration of reports of adverse events in osteoarthritis patients taking tanezumab, and the agency's concerns regarding the potential for such events in other patient populations in which the compound is being studied. The news comes less than four weeks after Pfizer announced the suspension of tanezumab studies in patients with osteoarthritis (The Pharma Letter June 24).

For studies on clinical hold, recruitment of new patients and the dosing of existing patients are suspended, says Pfizer in its statement yesterday, adding that it will continue to work with the FDA to reach a common understanding about the appropriate scope of continued clinical investigation of tanezumab.